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AI May Help Docs Reply to Patients’ Portal Messages

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Fri, 03/22/2024 - 13:01

Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

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Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

Among the potential uses envisioned for artificial intelligence (AI) in healthcare is decreasing provider burden by using the technology to help respond to patients’ questions submitted through portals.

Easing the burden on providers of responding to each question is a target ripe for solutions as during the COVID pandemic, such messages increased 157% from prepandemic levels, say authors of a paper published online in JAMA Network Open. Each additional message added 2.3 minutes to time spent on the electronic health record (EHR) per day.

Researchers at Stanford Health Care, led by Patricia Garcia, MD, with the department of medicine, conducted a 5-week, prospective, single-group quality improvement study from July 10 through August 13, 2023, at Stanford to test an AI response system.
 

Large Language Model Used

All attending physicians, advanced practice providers, clinic nurses, and clinical pharmacists from the divisions of primary care and gastroenterology and hepatology were enrolled in a pilot program that offered the option to answer patients’ questions with drafts that were generated by a Health Insurance Portability and Accountability Act–compliant large language model integrated into EHRs. Drafts were then reviewed by the provider.

The study primarily tested whether providers (162 were included) would use the AI-generated drafts. Secondary outcomes included whether using such a system saved time or improved the clinician experience.

Participants received survey emails before and after the pilot period and answered questions on areas including task load, EHR burden, usability, work exhaustion, burnout, and satisfaction.

Researchers found that the overall average utilization rate per clinician was 20% but there were significant between-group differences. For example, in gastroenterology and hepatology, nurses used the AI tool the most at 29% and physicians/APPs had a 24% usage rate, whereas clinical pharmacists had the highest use rate for primary care at 44% compared with physician use at 15%.
 

Burden Improved, But Didn’t Save Time

AI did not appear to save time but did improve task load scores and work exhaustion scores. The report states that there was no change in reply action time, write time, or read time between the prepilot and pilot periods. However, there were significant reductions in the physician task load score derivative (mean [SD], 61.31 [17.23] pre survey vs 47.26 [17.11] post survey; paired difference, −13.87; 95% CI, −17.38 to −9.50; P < .001) and work exhaustion scores decreased by a third (mean [SD], 1.95 [0.79] pre survey vs 1.62 [0.68] post survey; paired difference, −0.33; 95% CI, −0.50 to −0.17; P < .001)

The authors wrote that improvements in task load and emotional exhaustion scores suggest that generated replies have the potential to lessen cognitive burden and burnout. Though the AI tool didn’t save time, editing responses may be less cognitively taxing than writing responses for providers, the authors suggest.
 

Quality of AI Responses

Comments about AI response message voice and/or tone were the most common and had the highest absolute number of negative comments (10 positive, 2 neutral, and 14 negative). The most negative comments were about length (too long or too short) of the draft message (1 positive, 2 neutral, and 8 negative).

Comments on accuracy of the draft response were fairly even ­— 4 positive and 5 negative — but there were no adverse safety signals, the authors report.

The providers had high expectations about use and quality of the tool that “were either met or exceeded at the end of the pilot,” Dr. Garcia and coauthors write. “Given the evidence that burnout is associated with turnover, reductions in clinical activity, and quality, even a modest improvement may have a substantial impact.”

One coauthor reported grants from Google, Omada Health, and PredictaMed outside the submitted work. Another coauthor reported having a patent for Well-being Index Instruments and Mayo Leadership Impact Index, with royalties paid from Mayo Clinic, and receiving honoraria for presenting grand rounds, keynote lectures, and advising health care organizations on clinician well-being. No other disclosures were reported. 

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Proposed Bill Could End Student Aid for US Med Schools With DEI Programs

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Changed
Thu, 03/21/2024 - 16:54

Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

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Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

Medical schools with diversity, equity, and inclusion (DEI) initiatives could lose federal funding under a new bill proposed this week in the US House of Representatives. 

The Embracing Anti-Discrimination, Unbiased Curricula, and Advancing Truth in Education (EDUCATE) Act was introduced March 19 by North Carolina Rep. Greg Murphy (R-NC3). It aims to ban what the bill describes as “race-based mandates” at medical schools. 

The legislation highlights a larger national backlash, largely led by conservatives, against considering race and ethnicity in higher education after the Supreme Court overturned affirmative action last summer. 

According to the bill’s text, medical schools must not “establish, maintain, or contract with a [DEI] office, or any other functional equivalent.” They must also agree that they will not force students or faculty to acknowledge that “America is an oppressive nation” or that “individuals should be adversely treated on the basis of their sex, race, ethnicity, religion, color, or national origin.” 

If H.R. 7725 passes, noncompliant medical schools would no longer receive federal funding or be eligible to participate in guaranteed student loan programs. 

Advocating for colorblind medical school admissions overlooks the racism that still exists in society, said Vanessa Grubbs, MD, MPH, nephrologist and cofounder of the nonprofit Black Doc Village. She told this news organization that bills like H.R. 7725 distract from the real work of diversifying the physician workforce to achieve equitable care for all. 

“There’s a huge body of literature that shows when there is racial or cultural concordance, people have better satisfaction and health outcomes,” said Dr. Grubbs. “It’s really telling that the first thing the people dreaming up these bills say is that by having a diverse workforce, it automatically means that you have a less qualified workforce or that you’re lowering standards.”

The bill joins dozens of state legislative actions seeking to ban DEI principles in healthcare.

This week, Alabama legislators passed a bill prohibiting public universities from establishing DEI programs or using state money to sponsor events involving “divisive concepts.” If signed by the governor, the bill would go into effect on October 1, 2024, joining states like Tennessee and Utah with similar laws already on the books.

Industry groups are also grappling with anti-DEI sentiment. Earlier this month, the American Academy of Dermatology’s annual meeting took an unexpected turn when a member physician and 92 colleagues petitioned the academy to end its DEI programs, including scholarships and mentoring. A committee hearing the petition declined to send it to the Academy’s board.

Rep. Murphy, a urology surgeon who wrote a related editorial in the Wall Street Journal, argued that DEI ideology violates freedom of speech and allows medical schools to reject candidates for not being progressive enough. In the opinion piece, he and coauthor nephrologist Stanley Goldfarb, MD, referred to DEI efforts as “quackery” and a form of discrimination. 

Dr. Goldfarb is the chairman of Do No Harm, a Virginia-based advocacy group that has pushed to eradicate “identity politics” in medical education and clinical practice. The group was instrumental in suing the Louisiana governor for a law requiring that minority candidates fill some state medical board positions. It also filed a complaint against the Medical Board of California on behalf of two physicians, claiming the state’s mandated implicit bias training for healthcare professionals violates their First Amendment rights.

Following the Supreme Court’s ruling overturning affirmative action, the American Medical Association (AMA) adopted a policy advising medical schools to consider race as a factor in admissions alongside other criteria such as test scores, grades, and interviews. The policy provides a “necessary safeguard” to diversify the physician workforce and advance health equity, the AMA said at the time. 

The Association of American Medical Colleges supports DEI principles in medical education while advocating for race-neutral admissions practices like holistic review. This method considers the whole applicant, including their experiences, attributes, academic achievements, and the value they bring to the learning environment. 

H.R. 7725 has 35 cosponsors, many of whom are physicians. Podiatrist and Ohio Rep. Brad Wenstrup (R) said in a statement that medical education should be “free of discrimination” and that the bill would prevent physicians from “being forced to pledge, affirm, or adopt tenets that have infiltrated higher education.”

A version of this article appeared on Medscape.com .

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Study Links Maternal Hidradenitis Suppurativa to Risk for Childhood Morbidity

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Thu, 03/21/2024 - 11:04

Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 



The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

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Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 



The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

Maternal hidradenitis suppurativa (HS) is associated with an increased risk for adverse birth outcomes and childhood morbidities, including respiratory, metabolic, central nervous system, and other conditions.

Those are key findings from a longitudinal cohort study that was presented during a poster session at the annual meeting of the American Academy of Dermatology.

“HS is associated with morbidity in women of reproductive age and adverse pregnancy outcomes, [but] its effect on offspring outcomes remains unclear,” corresponding author Kaiyang Li, a third-year medical student at McGill University, Quebec, Canada, and coauthors wrote in their abstract.

To investigate the association between maternal HS and offspring outcomes at birth and with up to 16 years of follow-up, the researchers drew from a longitudinal cohort of 1,275,593 children born in Quebec between April 1, 2006 and March 31, 2022. They matched children with their mothers and used identification numbers to follow the children to note morbidities that led to hospital admissions before age 16 years. The exposure of interest was HS, and the main outcome measure was childhood hospitalizations for respiratory, cardiovascular, metabolic, and other morbidities prior to age 16 years. 

Next, they estimated hazard ratios (HR) and 95% CIs for the association of maternal HS with childhood morbidity in adjusted Cox proportional hazards regression models. “As prenatal exposure to hyperandrogenism may influence boys and girls differently, we carried out subgroup analyses stratified by child sex,” they wrote. 



The study population included 1283 children whose mothers had HS and 1,274,310 unexposed children. As for infant outcomes, compared with no exposure, maternal HS was associated with an increased risk for preterm birth (relative risk [RR], 1.29; 95% CI, 1,08-1.55), neonatal death (RR, 2.07; 95% CI, 1.03-14.13), birth defects (RR, 1.29; 95% CI, 1.07-1.56), congenital heart defects (RR, 1.57; 95% CI, 1.02-2.44), and orofacial defects (RR 4.29; 95% CI, 1.85-9.97).

As for long-term outcomes in the children, compared with those whose mothers did not have HS, maternal HS was associated with an increased risk for any childhood hospitalization (HR, 1.31; 95% CI, 1.19-1.44), respiratory hospitalization (HR, 1.21; 95% CI, 1.05-1.40), metabolic hospitalization (HR, 2.64; 95% CI, 1.67-4.20), gastrointestinal hospitalization (HR, 1.34; 95% CI, 1.03-1.74), and developmental hospitalization (HR, 1.92; 95% CI, 1.43-2.58).

Commenting on the results after the meeting, Ms. Li said that the findings support the need for timely management of HS in expectant mothers and people planning to conceive, and for “interdisciplinary care and follow up for both the mother and the baby, involving the dermatologist, the obstetrician, and the neonatologist or pediatrician if needed.”

“HS is a multidisciplinary disease, plain and simple,” Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, who was asked to comment on the study, said in an interview. “This study highlights the importance of collaboration between dermatology and obstetrician-gynecologist given the potential negative pregnancy outcomes, but to me raising alarm bells given the known gaps and delays in diagnosis matched to disease onset,” said Dr. Friedman, who was not involved with the study. “We need to do better to ensure the safety of both patient and patient-to-be.”

The researchers reported having no financial disclosures. The abstract was selected as the second-place winner in the AAD’s poster competition. Dr. Friedman has no relevant disclosures.

A version of this article appeared on Medscape.com.

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Most Cancer Trial Centers Located Closer to White, Affluent Populations

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Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.

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Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.

Most major cancer trial centers in the United States are located closer to populations with higher proportions of White, affluent individuals, a new study finds.

This inequity may be potentiating the underrepresentation of racially minoritized and socioeconomically disadvantaged populations in clinical trials, suggesting that employment of satellite hospitals is needed to expand access to investigational therapies, reported lead author Hassal Lee, MD, PhD, of Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, and colleagues.

“Minoritized and socioeconomically disadvantaged populations are underrepresented in clinical trials,” the investigators wrote in JAMA Oncology. “This may reduce the generalizability of trial results and propagate health disparities. Contributors to inequitable trial participation include individual-level factors and structural factors.”

Specifically, travel time to trial centers, as well as socioeconomic deprivation, can reduce likelihood of trial participation.

“Data on these parameters and population data on self-identified race exist, but their interrelation with clinical research facilities has not been systematically analyzed,” they wrote.

To try to draw comparisons between the distribution of patients of different races and socioeconomic statuses and the locations of clinical research facilities, Dr. Lee and colleagues aggregated data from the US Census, National Trial registry, Nature Index of Cancer Research Health Institutions, OpenStreetMap, National Cancer Institute–designated Cancer Centers list, and National Homeland Infrastructure Foundation. They then characterized catchment population demographics within 30-, 60-, and 120-minute driving commute times of all US hospitals, along with a more focused look at centers capable of conducting phase 1, phase 2, and phase 3 trials.

These efforts revealed broad geographic inequity.The 78 major centers that conduct 94% of all US cancer trials are located within 30 minutes of populations that have a 10.1% higher proportion of self-identified White individuals than the average US county, and a median income $18,900 higher than average (unpaired mean differences).

The publication also includes several maps characterizing racial and socioeconomic demographics within various catchment areas. For example, centers in New York City, Houston, and Chicago have the most diverse catchment populations within a 30-minute commute. Maps of all cities in the United States with populations greater than 500,000 are available in a supplementary index.

“This study indicates that geographical population distributions may present barriers to equitable clinical trial access and that data are available to proactively strategize about reduction of such barriers,” Dr. Lee and colleagues wrote.

The findings call attention to modifiable socioeconomic factors associated with trial participation, they added, like financial toxicity and affordable transportation, noting that ethnic and racial groups consent to trials at similar rates after controlling for income.

In addition, Dr. Lee and colleagues advised clinical trial designers to enlist satellite hospitals to increase participant diversity, since long commutes exacerbate “socioeconomic burdens associated with clinical trial participation,” with trial participation decreasing as commute time increases.

“Existing clinical trial centers may build collaborative efforts with nearby hospitals closer to underrepresented populations or set up community centers to support new collaborative networks to improve geographical access equity,” they wrote. “Methodologically, our approach is transferable to any country, region, or global effort with sufficient source data and can inform decision-making along the continuum of cancer care, from screening to implementing specialist care.”

A coauthor disclosed relationships with Flagship Therapeutics, Leidos Holding Ltd, Pershing Square Foundation, and others.

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Acne Risk With Progestin-Only Long-Acting Reversible Contraceptives Evaluated

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TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

  • Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
  • In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
  • Overall, 24% of participants had acne at the time of LARC insertion.
  • Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

  • During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
  • Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
  • Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

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TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

  • Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
  • In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
  • Overall, 24% of participants had acne at the time of LARC insertion.
  • Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

  • During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
  • Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
  • Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

 

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

  • Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
  • In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
  • Overall, 24% of participants had acne at the time of LARC insertion.
  • Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

  • During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
  • Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
  • Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

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ctDNA May Predict Early Response to Radiation of Gynecologic Cancers

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Wed, 03/20/2024 - 16:12

Circulating tumor DNA (ctDNA) testing may serve as an early predictor of response to radiotherapy or chemoradiotherapy in patients with gynecologic cancers, results of a small study suggest.

Among 15 patients with vulvar, cervical, or endometrial malignancies who had serum ctDNA draws prior to, during, and after radiation therapy (RT) or chemoradiotherapy (CRT), both persistence or clearance of residual ctDNA were prognostic of patient outcomes from 3 to 6 months after the end of radiation therapy, reported A. Gabriella Wernicke, MD, MSc, a radiation oncologist at Lenox Hill Hospital in New York City.

“Our early findings in this limited cohort suggest that a mid-treatment ctDNA draw identified responders to radiation, and that may potentially serve as an early predictive biomarker of response. And clearly, these findings need to be validated in a prospective manner, a trial which will be starting in our center soon,” she said in an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego, California.

Gynecologic malignancies are challenging to manage with radiotherapy because of the treatment’s toxicities and because outcomes may not be known until several months after the end of therapy. Early identification of responses to radiation therapy with simple blood draws has the potential to help clinicians identify those patients whose tumors are responding to radiation early in the course of therapy, she said.
 

Correlating treatment with responses

Dr. Wernicke and colleagues tested their hypothesis that the ctDNA is predictive of treatment response in patients receiving RT or CRT by retrospectively assessing the correlation of clinical responses to ctDNA detection and dynamics.

Their sample included 15 women with vulvar, cervical, or recurrent endometrial cancer who were treated with RT or CRT in 2022 and 2023.

The samples were collected prior to radiation therapy, mid-treatment, prior to boost dose with brachytherapy or stereotactic body radiation therapy, at the end of treatment, and at follow-up at 1, 3, and 6 months after the end of therapy and every 6 months thereafter.

The ctDNA analysis was performed with a personalized assay consisting of multiplex polymerase chain reaction and next-generation sequencing. The assays assessed clonal mutations found in the tumors of each patient.

Of the 15 patients, 5 had vulvar/vaginal tumors, all of squamous cell carcinoma histology. Six patients had squamous cell carcinoma of the cervix, and one had neuroendocrine cervical tumors. The two remaining patients had recurrent endometrial adenocarcinomas.

Eight of the patients had stage III disease, four had stage I or II, one had stage IV, and two had recurrent disease.
 

Results

At baseline 13 of the patients had detectable ctDNA, measured as greater than 0.00 mean tumor molecules per milliliter of plasma (MTM/mL).

There was a strong correlation between elevated ctDNA and measurable disease evaluated by standardized uptake values (SUV) on imaging pre treatment (correlation coefficient = 0.87, P less than .0001).

All patients had reductions in ctDNA from baseline to post-RT/CRT, with 2 having a reduction (partial metabolic response) and 13 having undetectable ctDNA (complete metabolic response) at the end of RT/CRT.

From the mid-treatment blood draw to the posttreatment draw 33% of patients had a partial metabolic response, and 67% had a complete response.

Reduction or clearance of ctDNA also correlated with a decrease in disease burden on MRI during the pre-boost phase of RT.

“Patients with undetectable ctDNA, meaning a complete metabolic response, at mid-radiation and at the end of radiation continued to be clinically without evidence of disease and with undetectable ctDNA at follow-up,” Dr. Wernicke said.

In contrast, the two patients who had partial metabolic responses had disease progression at the end of treatment. Dr. Wernicke noted that one of these patients, who was treated for a neuroendocrine carcinoma of the cervix and had undergone both systemic therapy and CRT, was found to have disease metastatic to the liver and lungs at the 3-month follow-up.
 

 

 

How to Use It?

Invited discussant Casey M. Cosgrove, MD, a gynecologic oncologist at Ohio State University Comprehensive Cancer Centers facility in Hilliard, Ohio, said that the reduction of ctDNA levels in all patients was “great,” but the question remains about how the information from ctDNA might be used to guide care in patients undergoing radiation therapy.

“The main questions I have are: If I don’t clear the ctDNA do I need to do more therapy? If I do clear does that mean I need to do less therapy? And if I have negative ctDNA to start what do I do?” he said.

The answers will be found only with further prospective studies, he emphasized.

“These technologies are only going to get better, and better, and better, and this is going to be a conversation that our patients are going to be bringing up, and this is going to be technology that we’re going to be using in our clinics in the very near future,” he added.

Session comoderator Michael Bookman, MD, a gynecology oncologist at Kaiser Permanente in San Francisco, said “it’s worth remembering that FDA approval of a diagnostic test can be obtained prior to showing any clinical benefit. So these are tests that measure what they say they’re measuring, but they haven’t been validated as improving clinical outcomes, which is the task that clearly lies ahead of us.”

The study was internally funded. Dr. Wernicke reported no relevant disclosures. Dr. Cosgrove reported a consulting or advisory role for Intuitive Ltd., GlaxoSmithKline, AstraZeneca, ImmunoGen, and Merck, and research fees from GSK. Dr. Bookman reported clinical trial advising/monitoring for Immunogen and Clovis Oncology, with fees paid to his institution.

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Circulating tumor DNA (ctDNA) testing may serve as an early predictor of response to radiotherapy or chemoradiotherapy in patients with gynecologic cancers, results of a small study suggest.

Among 15 patients with vulvar, cervical, or endometrial malignancies who had serum ctDNA draws prior to, during, and after radiation therapy (RT) or chemoradiotherapy (CRT), both persistence or clearance of residual ctDNA were prognostic of patient outcomes from 3 to 6 months after the end of radiation therapy, reported A. Gabriella Wernicke, MD, MSc, a radiation oncologist at Lenox Hill Hospital in New York City.

“Our early findings in this limited cohort suggest that a mid-treatment ctDNA draw identified responders to radiation, and that may potentially serve as an early predictive biomarker of response. And clearly, these findings need to be validated in a prospective manner, a trial which will be starting in our center soon,” she said in an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego, California.

Gynecologic malignancies are challenging to manage with radiotherapy because of the treatment’s toxicities and because outcomes may not be known until several months after the end of therapy. Early identification of responses to radiation therapy with simple blood draws has the potential to help clinicians identify those patients whose tumors are responding to radiation early in the course of therapy, she said.
 

Correlating treatment with responses

Dr. Wernicke and colleagues tested their hypothesis that the ctDNA is predictive of treatment response in patients receiving RT or CRT by retrospectively assessing the correlation of clinical responses to ctDNA detection and dynamics.

Their sample included 15 women with vulvar, cervical, or recurrent endometrial cancer who were treated with RT or CRT in 2022 and 2023.

The samples were collected prior to radiation therapy, mid-treatment, prior to boost dose with brachytherapy or stereotactic body radiation therapy, at the end of treatment, and at follow-up at 1, 3, and 6 months after the end of therapy and every 6 months thereafter.

The ctDNA analysis was performed with a personalized assay consisting of multiplex polymerase chain reaction and next-generation sequencing. The assays assessed clonal mutations found in the tumors of each patient.

Of the 15 patients, 5 had vulvar/vaginal tumors, all of squamous cell carcinoma histology. Six patients had squamous cell carcinoma of the cervix, and one had neuroendocrine cervical tumors. The two remaining patients had recurrent endometrial adenocarcinomas.

Eight of the patients had stage III disease, four had stage I or II, one had stage IV, and two had recurrent disease.
 

Results

At baseline 13 of the patients had detectable ctDNA, measured as greater than 0.00 mean tumor molecules per milliliter of plasma (MTM/mL).

There was a strong correlation between elevated ctDNA and measurable disease evaluated by standardized uptake values (SUV) on imaging pre treatment (correlation coefficient = 0.87, P less than .0001).

All patients had reductions in ctDNA from baseline to post-RT/CRT, with 2 having a reduction (partial metabolic response) and 13 having undetectable ctDNA (complete metabolic response) at the end of RT/CRT.

From the mid-treatment blood draw to the posttreatment draw 33% of patients had a partial metabolic response, and 67% had a complete response.

Reduction or clearance of ctDNA also correlated with a decrease in disease burden on MRI during the pre-boost phase of RT.

“Patients with undetectable ctDNA, meaning a complete metabolic response, at mid-radiation and at the end of radiation continued to be clinically without evidence of disease and with undetectable ctDNA at follow-up,” Dr. Wernicke said.

In contrast, the two patients who had partial metabolic responses had disease progression at the end of treatment. Dr. Wernicke noted that one of these patients, who was treated for a neuroendocrine carcinoma of the cervix and had undergone both systemic therapy and CRT, was found to have disease metastatic to the liver and lungs at the 3-month follow-up.
 

 

 

How to Use It?

Invited discussant Casey M. Cosgrove, MD, a gynecologic oncologist at Ohio State University Comprehensive Cancer Centers facility in Hilliard, Ohio, said that the reduction of ctDNA levels in all patients was “great,” but the question remains about how the information from ctDNA might be used to guide care in patients undergoing radiation therapy.

“The main questions I have are: If I don’t clear the ctDNA do I need to do more therapy? If I do clear does that mean I need to do less therapy? And if I have negative ctDNA to start what do I do?” he said.

The answers will be found only with further prospective studies, he emphasized.

“These technologies are only going to get better, and better, and better, and this is going to be a conversation that our patients are going to be bringing up, and this is going to be technology that we’re going to be using in our clinics in the very near future,” he added.

Session comoderator Michael Bookman, MD, a gynecology oncologist at Kaiser Permanente in San Francisco, said “it’s worth remembering that FDA approval of a diagnostic test can be obtained prior to showing any clinical benefit. So these are tests that measure what they say they’re measuring, but they haven’t been validated as improving clinical outcomes, which is the task that clearly lies ahead of us.”

The study was internally funded. Dr. Wernicke reported no relevant disclosures. Dr. Cosgrove reported a consulting or advisory role for Intuitive Ltd., GlaxoSmithKline, AstraZeneca, ImmunoGen, and Merck, and research fees from GSK. Dr. Bookman reported clinical trial advising/monitoring for Immunogen and Clovis Oncology, with fees paid to his institution.

Circulating tumor DNA (ctDNA) testing may serve as an early predictor of response to radiotherapy or chemoradiotherapy in patients with gynecologic cancers, results of a small study suggest.

Among 15 patients with vulvar, cervical, or endometrial malignancies who had serum ctDNA draws prior to, during, and after radiation therapy (RT) or chemoradiotherapy (CRT), both persistence or clearance of residual ctDNA were prognostic of patient outcomes from 3 to 6 months after the end of radiation therapy, reported A. Gabriella Wernicke, MD, MSc, a radiation oncologist at Lenox Hill Hospital in New York City.

“Our early findings in this limited cohort suggest that a mid-treatment ctDNA draw identified responders to radiation, and that may potentially serve as an early predictive biomarker of response. And clearly, these findings need to be validated in a prospective manner, a trial which will be starting in our center soon,” she said in an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego, California.

Gynecologic malignancies are challenging to manage with radiotherapy because of the treatment’s toxicities and because outcomes may not be known until several months after the end of therapy. Early identification of responses to radiation therapy with simple blood draws has the potential to help clinicians identify those patients whose tumors are responding to radiation early in the course of therapy, she said.
 

Correlating treatment with responses

Dr. Wernicke and colleagues tested their hypothesis that the ctDNA is predictive of treatment response in patients receiving RT or CRT by retrospectively assessing the correlation of clinical responses to ctDNA detection and dynamics.

Their sample included 15 women with vulvar, cervical, or recurrent endometrial cancer who were treated with RT or CRT in 2022 and 2023.

The samples were collected prior to radiation therapy, mid-treatment, prior to boost dose with brachytherapy or stereotactic body radiation therapy, at the end of treatment, and at follow-up at 1, 3, and 6 months after the end of therapy and every 6 months thereafter.

The ctDNA analysis was performed with a personalized assay consisting of multiplex polymerase chain reaction and next-generation sequencing. The assays assessed clonal mutations found in the tumors of each patient.

Of the 15 patients, 5 had vulvar/vaginal tumors, all of squamous cell carcinoma histology. Six patients had squamous cell carcinoma of the cervix, and one had neuroendocrine cervical tumors. The two remaining patients had recurrent endometrial adenocarcinomas.

Eight of the patients had stage III disease, four had stage I or II, one had stage IV, and two had recurrent disease.
 

Results

At baseline 13 of the patients had detectable ctDNA, measured as greater than 0.00 mean tumor molecules per milliliter of plasma (MTM/mL).

There was a strong correlation between elevated ctDNA and measurable disease evaluated by standardized uptake values (SUV) on imaging pre treatment (correlation coefficient = 0.87, P less than .0001).

All patients had reductions in ctDNA from baseline to post-RT/CRT, with 2 having a reduction (partial metabolic response) and 13 having undetectable ctDNA (complete metabolic response) at the end of RT/CRT.

From the mid-treatment blood draw to the posttreatment draw 33% of patients had a partial metabolic response, and 67% had a complete response.

Reduction or clearance of ctDNA also correlated with a decrease in disease burden on MRI during the pre-boost phase of RT.

“Patients with undetectable ctDNA, meaning a complete metabolic response, at mid-radiation and at the end of radiation continued to be clinically without evidence of disease and with undetectable ctDNA at follow-up,” Dr. Wernicke said.

In contrast, the two patients who had partial metabolic responses had disease progression at the end of treatment. Dr. Wernicke noted that one of these patients, who was treated for a neuroendocrine carcinoma of the cervix and had undergone both systemic therapy and CRT, was found to have disease metastatic to the liver and lungs at the 3-month follow-up.
 

 

 

How to Use It?

Invited discussant Casey M. Cosgrove, MD, a gynecologic oncologist at Ohio State University Comprehensive Cancer Centers facility in Hilliard, Ohio, said that the reduction of ctDNA levels in all patients was “great,” but the question remains about how the information from ctDNA might be used to guide care in patients undergoing radiation therapy.

“The main questions I have are: If I don’t clear the ctDNA do I need to do more therapy? If I do clear does that mean I need to do less therapy? And if I have negative ctDNA to start what do I do?” he said.

The answers will be found only with further prospective studies, he emphasized.

“These technologies are only going to get better, and better, and better, and this is going to be a conversation that our patients are going to be bringing up, and this is going to be technology that we’re going to be using in our clinics in the very near future,” he added.

Session comoderator Michael Bookman, MD, a gynecology oncologist at Kaiser Permanente in San Francisco, said “it’s worth remembering that FDA approval of a diagnostic test can be obtained prior to showing any clinical benefit. So these are tests that measure what they say they’re measuring, but they haven’t been validated as improving clinical outcomes, which is the task that clearly lies ahead of us.”

The study was internally funded. Dr. Wernicke reported no relevant disclosures. Dr. Cosgrove reported a consulting or advisory role for Intuitive Ltd., GlaxoSmithKline, AstraZeneca, ImmunoGen, and Merck, and research fees from GSK. Dr. Bookman reported clinical trial advising/monitoring for Immunogen and Clovis Oncology, with fees paid to his institution.

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What Do Sex Therapists Do? (Hint: It’s Not What You Think)

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This transcript has been edited for clarity.

Rachel S. Rubin, MD: We are here at the Harvard Continuing Medical Education Course in Orlando, Florida. It’s all about testosterone therapy and sexual medicine. I have with me today the wonderful Dr. Marianne Brandon, who is an amazing sex therapist. Could you introduce yourself?

Marianne Brandon, PhD: I am a clinical psychologist and sex therapist. I’ve been in practice for more than 25 years. I’m currently located in Sarasota. I have a Psychology Today blog called The Future of Intimacy, which I have a lot of fun with.

Dr. Rubin: It’s very important, when taking care of patients, that we work in a biopsychosocial model. Yes, we can fix erectile dysfunction. We can help with menopause symptoms and that helps sexual function. But what I find makes my patients able to live their best lives is when they have a team, including a mental health professional — often a sex therapist or a couples’ therapist — where they can learn communication skills. Why is it important for primary care doctors to talk to their patients about sex? My primary care doctor has never asked me about sex.  

Dr. Brandon: For most people, sexual intimacy is critical for their experience of life. It correlates with their relationship satisfaction and life satisfaction. It’s much bigger than what’s happening in the bedroom. People have more struggles than you realize. Sexual dysfunction correlates with emotional issues such as depression and anxiety, with medical problems, and with medication use. Chances are that your patients have some kind of sexual concern, even if that’s not to the degree that it would be classified as a sexual dysfunction.

But sexual concerns wreak havoc. Believing they have a sexual problem, they stop touching, they stop relating to their partner. It becomes a really big deal in their lives. If you can open the door for a conversation about sex with your patients, it could do them a great deal of good. It’s also good for the practitioner, because if your patients think they can talk with you about anything, that’s going to establish your relationship with them. Practitioners avoid these conversations because they don’t have the time or the training to offer help.

Dr. Rubin: You don’t have to know all the answers. You just have to show empathy and compassion and say, “I hear you.” That’s the magic in the doctor-patient relationship. We refer patients to specialists when we don’t know what to do. What happens when I send a patient to a sex therapist? Do they watch them have sex? Of course not, but everyone thinks that is what sex therapists do.

Dr. Brandon: Sex therapy is just like any other type of therapy, but we discuss sexual issues. And because just about anything that’s happening in your patient’s life can trickle down into the bedroom, we end up talking about a lot of stuff that’s not directly related to sex but ultimately impacts the patient’s sex life.

Dr. Rubin: It’s true. Most medical conditions that we treat — from diabetes, hypertension, high cholesterol, and obesity to depression and anxiety — are strongly correlated with sexual health. We treat the underlying condition, but our patients don’t care about their A1c levels. They care about the fact that they cannot get aroused; their genitals don’t feel the same way they used to.

Dr. Brandon: I love that point because people make meaning out of their sexual concerns and dysfunction. Suddenly their body isn’t responding the way it used to. They think something’s wrong with them, or maybe they are with the wrong partner. This meaning becomes very powerful in their mind and perpetuates the sexual problem.

Dr. Rubin: First and foremost, we are educators. We can say, “You have pretty out-of-control diabetes,” or, “You’re a smoker, which can affect the health of your genitals. Have you noticed any issues going on there?” If you don’t ask, patients will not bring up their concerns with their doctors.

So how do people find a sex therapist?

Dr. Brandon: There are a few fabulous organizations that provide on their websites ways to find a therapist: the American Association of Sex Educators, Counselors and Therapists (AASECT) and Sex Therapy and Research (STAR). Giving patients this information is a huge intervention.

Other places to find a therapist include the International Society for Sexual Medicine, and the International Society for the Study of Women’s Sexual Health.

Since COVID, many therapists have gone virtual. Encourage your patients to look within their states to find options for therapists and psychologists. Recent legislation allows psychologists who have signed up for PSYPACT to practice almost throughout the entire United States. We used to think if we didn’t have a therapist in the community, we couldn’t make a referral. That›s not the case anymore.

Dr. Rubin: All doctors are really sexual medicine doctors. We can change the whole world by giving our patients a better quality of life.
 

Dr. Rubin, Assistant Clinical Professor, Department of Urology, Georgetown University, Washington, disclosed ties to Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity.

Rachel S. Rubin, MD: We are here at the Harvard Continuing Medical Education Course in Orlando, Florida. It’s all about testosterone therapy and sexual medicine. I have with me today the wonderful Dr. Marianne Brandon, who is an amazing sex therapist. Could you introduce yourself?

Marianne Brandon, PhD: I am a clinical psychologist and sex therapist. I’ve been in practice for more than 25 years. I’m currently located in Sarasota. I have a Psychology Today blog called The Future of Intimacy, which I have a lot of fun with.

Dr. Rubin: It’s very important, when taking care of patients, that we work in a biopsychosocial model. Yes, we can fix erectile dysfunction. We can help with menopause symptoms and that helps sexual function. But what I find makes my patients able to live their best lives is when they have a team, including a mental health professional — often a sex therapist or a couples’ therapist — where they can learn communication skills. Why is it important for primary care doctors to talk to their patients about sex? My primary care doctor has never asked me about sex.  

Dr. Brandon: For most people, sexual intimacy is critical for their experience of life. It correlates with their relationship satisfaction and life satisfaction. It’s much bigger than what’s happening in the bedroom. People have more struggles than you realize. Sexual dysfunction correlates with emotional issues such as depression and anxiety, with medical problems, and with medication use. Chances are that your patients have some kind of sexual concern, even if that’s not to the degree that it would be classified as a sexual dysfunction.

But sexual concerns wreak havoc. Believing they have a sexual problem, they stop touching, they stop relating to their partner. It becomes a really big deal in their lives. If you can open the door for a conversation about sex with your patients, it could do them a great deal of good. It’s also good for the practitioner, because if your patients think they can talk with you about anything, that’s going to establish your relationship with them. Practitioners avoid these conversations because they don’t have the time or the training to offer help.

Dr. Rubin: You don’t have to know all the answers. You just have to show empathy and compassion and say, “I hear you.” That’s the magic in the doctor-patient relationship. We refer patients to specialists when we don’t know what to do. What happens when I send a patient to a sex therapist? Do they watch them have sex? Of course not, but everyone thinks that is what sex therapists do.

Dr. Brandon: Sex therapy is just like any other type of therapy, but we discuss sexual issues. And because just about anything that’s happening in your patient’s life can trickle down into the bedroom, we end up talking about a lot of stuff that’s not directly related to sex but ultimately impacts the patient’s sex life.

Dr. Rubin: It’s true. Most medical conditions that we treat — from diabetes, hypertension, high cholesterol, and obesity to depression and anxiety — are strongly correlated with sexual health. We treat the underlying condition, but our patients don’t care about their A1c levels. They care about the fact that they cannot get aroused; their genitals don’t feel the same way they used to.

Dr. Brandon: I love that point because people make meaning out of their sexual concerns and dysfunction. Suddenly their body isn’t responding the way it used to. They think something’s wrong with them, or maybe they are with the wrong partner. This meaning becomes very powerful in their mind and perpetuates the sexual problem.

Dr. Rubin: First and foremost, we are educators. We can say, “You have pretty out-of-control diabetes,” or, “You’re a smoker, which can affect the health of your genitals. Have you noticed any issues going on there?” If you don’t ask, patients will not bring up their concerns with their doctors.

So how do people find a sex therapist?

Dr. Brandon: There are a few fabulous organizations that provide on their websites ways to find a therapist: the American Association of Sex Educators, Counselors and Therapists (AASECT) and Sex Therapy and Research (STAR). Giving patients this information is a huge intervention.

Other places to find a therapist include the International Society for Sexual Medicine, and the International Society for the Study of Women’s Sexual Health.

Since COVID, many therapists have gone virtual. Encourage your patients to look within their states to find options for therapists and psychologists. Recent legislation allows psychologists who have signed up for PSYPACT to practice almost throughout the entire United States. We used to think if we didn’t have a therapist in the community, we couldn’t make a referral. That›s not the case anymore.

Dr. Rubin: All doctors are really sexual medicine doctors. We can change the whole world by giving our patients a better quality of life.
 

Dr. Rubin, Assistant Clinical Professor, Department of Urology, Georgetown University, Washington, disclosed ties to Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Rachel S. Rubin, MD: We are here at the Harvard Continuing Medical Education Course in Orlando, Florida. It’s all about testosterone therapy and sexual medicine. I have with me today the wonderful Dr. Marianne Brandon, who is an amazing sex therapist. Could you introduce yourself?

Marianne Brandon, PhD: I am a clinical psychologist and sex therapist. I’ve been in practice for more than 25 years. I’m currently located in Sarasota. I have a Psychology Today blog called The Future of Intimacy, which I have a lot of fun with.

Dr. Rubin: It’s very important, when taking care of patients, that we work in a biopsychosocial model. Yes, we can fix erectile dysfunction. We can help with menopause symptoms and that helps sexual function. But what I find makes my patients able to live their best lives is when they have a team, including a mental health professional — often a sex therapist or a couples’ therapist — where they can learn communication skills. Why is it important for primary care doctors to talk to their patients about sex? My primary care doctor has never asked me about sex.  

Dr. Brandon: For most people, sexual intimacy is critical for their experience of life. It correlates with their relationship satisfaction and life satisfaction. It’s much bigger than what’s happening in the bedroom. People have more struggles than you realize. Sexual dysfunction correlates with emotional issues such as depression and anxiety, with medical problems, and with medication use. Chances are that your patients have some kind of sexual concern, even if that’s not to the degree that it would be classified as a sexual dysfunction.

But sexual concerns wreak havoc. Believing they have a sexual problem, they stop touching, they stop relating to their partner. It becomes a really big deal in their lives. If you can open the door for a conversation about sex with your patients, it could do them a great deal of good. It’s also good for the practitioner, because if your patients think they can talk with you about anything, that’s going to establish your relationship with them. Practitioners avoid these conversations because they don’t have the time or the training to offer help.

Dr. Rubin: You don’t have to know all the answers. You just have to show empathy and compassion and say, “I hear you.” That’s the magic in the doctor-patient relationship. We refer patients to specialists when we don’t know what to do. What happens when I send a patient to a sex therapist? Do they watch them have sex? Of course not, but everyone thinks that is what sex therapists do.

Dr. Brandon: Sex therapy is just like any other type of therapy, but we discuss sexual issues. And because just about anything that’s happening in your patient’s life can trickle down into the bedroom, we end up talking about a lot of stuff that’s not directly related to sex but ultimately impacts the patient’s sex life.

Dr. Rubin: It’s true. Most medical conditions that we treat — from diabetes, hypertension, high cholesterol, and obesity to depression and anxiety — are strongly correlated with sexual health. We treat the underlying condition, but our patients don’t care about their A1c levels. They care about the fact that they cannot get aroused; their genitals don’t feel the same way they used to.

Dr. Brandon: I love that point because people make meaning out of their sexual concerns and dysfunction. Suddenly their body isn’t responding the way it used to. They think something’s wrong with them, or maybe they are with the wrong partner. This meaning becomes very powerful in their mind and perpetuates the sexual problem.

Dr. Rubin: First and foremost, we are educators. We can say, “You have pretty out-of-control diabetes,” or, “You’re a smoker, which can affect the health of your genitals. Have you noticed any issues going on there?” If you don’t ask, patients will not bring up their concerns with their doctors.

So how do people find a sex therapist?

Dr. Brandon: There are a few fabulous organizations that provide on their websites ways to find a therapist: the American Association of Sex Educators, Counselors and Therapists (AASECT) and Sex Therapy and Research (STAR). Giving patients this information is a huge intervention.

Other places to find a therapist include the International Society for Sexual Medicine, and the International Society for the Study of Women’s Sexual Health.

Since COVID, many therapists have gone virtual. Encourage your patients to look within their states to find options for therapists and psychologists. Recent legislation allows psychologists who have signed up for PSYPACT to practice almost throughout the entire United States. We used to think if we didn’t have a therapist in the community, we couldn’t make a referral. That›s not the case anymore.

Dr. Rubin: All doctors are really sexual medicine doctors. We can change the whole world by giving our patients a better quality of life.
 

Dr. Rubin, Assistant Clinical Professor, Department of Urology, Georgetown University, Washington, disclosed ties to Sprout, Maternal Medical, Absorption Pharmaceuticals, GlaxoSmithKline, and Endo.

A version of this article appeared on Medscape.com.

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Non-Radical Surgery a Win-Win for Early Cervical Cancer

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Changed
Wed, 03/20/2024 - 12:44

For early-stage cervical cancer, non-radical surgery (simple hysterectomy or cone biopsy plus pelvic lymphadenectomy) appears safe with no lasting negative impact on quality of life, according to results of the GOG-278 trial.

In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer

“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.

Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.

He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”

GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.

The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.

Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.

Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.

In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.

He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
 

‘Impressive’ Data

Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”

She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.

Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.

The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.

Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.

A version of this article appeared on Medscape.com.

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For early-stage cervical cancer, non-radical surgery (simple hysterectomy or cone biopsy plus pelvic lymphadenectomy) appears safe with no lasting negative impact on quality of life, according to results of the GOG-278 trial.

In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer

“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.

Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.

He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”

GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.

The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.

Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.

Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.

In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.

He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
 

‘Impressive’ Data

Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”

She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.

Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.

The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.

Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.

A version of this article appeared on Medscape.com.

For early-stage cervical cancer, non-radical surgery (simple hysterectomy or cone biopsy plus pelvic lymphadenectomy) appears safe with no lasting negative impact on quality of life, according to results of the GOG-278 trial.

In fact, patients’ quality of life was improved after surgery in both groups, and their concerns about cancer recurrence decreased, especially for those undergoing simple hysterectomy, said Allan Covens, MD, in his late-breaking abstract presentation at the Society of Gynecologic Oncology (SGO)’s Annual Meeting on Women’s Cancer

“Cone biopsy patients reported less concerns about reproductive fertility after surgery and over time compared to preop assessments,” he added.

Due to screening in developed countries, a large proportion of cervical cancers are discovered at an early stage. Treatment of these cancers with radical surgery is associated with high cure rates but significant adverse effects on quality of life, said Dr. Covens, who is with the University of Toronto, Toronto, Ontario, Canada.

He and his colleagues wanted to see if non-radical surgery could be safely used instead. “Multiple case series have indicated that non-radical surgery is associated with less morbidity and improved quality of life,” he explained. “If this can be proven in a prospective evaluation, it will change future practice.”

GOG-278 was a prospective cohort study of women with stage IA1 (lymph-vascular space invasion+) and IA2-IB1 (≤ 2 cm) carcinoma of the cervix who underwent non-radical surgery (simple hysterectomy or fertility-preserving cone biopsy) and pelvic lymphadenectomy. Criteria included ≤ 10 mm stromal invasion and negative margins on the final cone biopsy.

The primary objectives were to assess changes in functional outcomes of quality of life (bladder/bowel function, sexual function, cancer worry, and reproductive concerns), using validated instruments. Findings were based on 55 patients who underwent cone biopsy and 113 who underwent simple hysterectomy.

Both simple hysterectomy and cone biopsy were associated with “small” declines in sexual function and bladder/bowel function at 4-6 weeks after surgery, but function “quickly” recovered to baseline by 6 months, Dr. Covens reported.

Twelve patients reported a diagnosis of lymphedema, with a Gynecologic Cancer Lymphedema Questionnaire score change of 4 or higher on at least two consecutive evaluations from baseline. This occurred in six cone biopsy and six simple hysterectomy patients.

In a separate presentation, Dr. Covens reported secondary oncologic outcomes from GOG-278, which suggest that non-radical surgery for early-stage cervical cancer is safe, with low perioperative morbidity, although longer follow-up is needed.

He also reported 16 pregnancies in 15 patients who had undergone cone biopsies; 12 of these were successful, and there were four early pregnancy losses.
 

‘Impressive’ Data

Study discussant Kristin Bixel, MD, with The Ohio State University, Columbus, Ohio, said the data are “impressive” and clearly show that non-radical surgery has “minimal impact on bladder/bowel function, with no long-term differences from baseline.”

She added that the incidence of lymphedema was “honestly significantly lower than what I typically counsel patients about” and wondered if the percentage of patients with lymphedema would increase over time.

Dr. Bixel particularly noted the decrease in cancer worry scores after surgery, as sometimes patients who have less radical procedures fear that this comes with an increased risk for recurrence.

The “growing body of data suggests that less radical surgery is safe and effective for early-stage low-risk cervical cancer and highlights the potential reproductive success,” she concluded.

Funding for the study was provided by grants from NRG Oncology. Dr. Covens had no disclosures. Dr. Bixel has received research funding from the Intuitive Foundation.

A version of this article appeared on Medscape.com.

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Debate Arises Over Ovarian Tissue Transplants to Delay Menopause

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Changed
Wed, 03/20/2024 - 11:34

The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

 

 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

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The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

 

 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

The transplantation of ovarian tissue is often performed to extend fertility among women and adolescents with cancer. But some reproductive specialists believe the procedure may have another role to play with much wider application: delaying, or even preventing, menopause in healthy women.

Kutluk Oktay, MD, director of the Laboratory of Molecular Reproduction and Fertility Preservation at the Yale School of Medicine in New Haven, Connecticut, has used ovarian tissue transplantation (OTT) in his own practice — Innovation Fertility Preservation & IVF — for several years. He said the approach can reduce health risks associated with menopause, such as the loss of bone density and cardiovascular disease.

“We have started offering [ovarian tissue transplantation] in carefully selected candidates, but the pace will accelerate now that we have a way to better inform the candidates on the potential of the procedure,” Dr. Oktay said. To date, he said he has performed the procedure on approximately 20 patients.

But Dr. Oktay’s vision of the future for OTT remains on the fringe of reproductive medicine.

“I think there are ethical considerations to take into account here,” said Stephanie Faubion, MD, Medical Director for the North American Menopause Society. “You’re taking a perfectly healthy 25- to 30-year-old woman and putting her through surgery to take out a healthy organ. Let’s just think about that.”
 

The Promise and Risks of OTT

OTT involves removing part of the ovarian tissue, cryopreservation, and then transplanting it back into the body. The procedure has reversed early menopause in women who underwent cancer treatment and resulted in over 140 live births worldwide.

Dr. Oktay recently published a nonclinical study in the American Journal of Obstetrics & Gynecology using a mathematical model based on decades of clinical research on cancer patients and ovarian follicle counts in cadaver to forecast how OTT can delay the onset of menopause through restored ovarian function and hormonal shifts.

The model forecasts a delay in menopause of up to 47 years, depending on factors such as the age of tissue removal, a woman’s ovarian reserve, and an estimated number of primordial follicles — where tens to hundreds of thousands of undeveloped eggs can live — that survive the process of removal, freezing, and reimplantation.

OTT is currently associated with a survival rate of 40% for follicles, Dr. Oktay said. But technological advancements, including revascularization drugs and robotic surgery, are likely to extend the survival rate to 80% by the time reimplantation occurs, potentially 15-20 years after tissue removal, he said.

Prospective patients at Dr. Oktay’s practice can use an interactive tool to receive an estimate of their potential menopausal delay. Patients receive a clinical assessment, including tests for ovarian reserve markers, to determine their potential for the procedure.

The model predicted that harvesting tissue before age 30 could delay menopause significantly. A 25-year-old woman with an average ovarian reserve who preserved a quarter of one ovary would have a delay in menopause of 11.8 years if 40% of the follicles survived. Women around age 40, and especially those with a low ovarian reserve, would need a follicle survival rate of close to 100% to result in a delay significant enough to justify the procedure.

The procedure also comes with risks. Removing ovarian tissue can bring on early menopause, Dr. Oktay said. Removing part or all of the ovarian cortex — the outer part of the ovary that contains the follicles — can start menopause about 1.5 years earlier. But as long as the tissue is transplanted, a woman would gain many more years of fertility before menopause.

While potentially promising, some obstetrics and gynecology experts question the procedure, with no proven benefits.

“While theoretically possible, my biggest question is, how is this better than egg freezing in your 20s or 30s combined with hormone replacement for the aging benefits, given the risks associated with potentially multiple surgeries?” said Paula Amato, MD, professor of obstetrics and gynecology at Oregon Health & Science University in Portland, Oregon.

Any risks associated with receiving hormone therapy through OTT rather than traditional hormone replacement therapy are also unknown, Dr. Amato said.

A UK clinic, ProFam, based in Birmingham, also offered the procedure but faced criticism in 2020 for being unnecessary and experimental. This news organization could not confirm if the clinic is still in operation.
 

 

 

Why Delay Menopause?

While the procedure may extend fertility, the goal of the procedure is not to enable patients to become pregnant at ages that are not safe, Dr. Oktay said. Rather, he said postponing menopause is medically beneficial.

Some research shows that women who have late menopause have a lower risk for all-cause mortality and cardiovascular disease but a higher risk for breast, endometrial, and ovarian cancers.

Dr. Oktay said that delaying menopause could improve the quality of life for women by reducing menopausal symptoms like anxiety and depression. Clinicians could also use the procedure as preventive care for those who are at high risk for conditions associated with menopause, such as osteoporosis and dementia.

But Dr. Faubion is unconvinced that delaying menopause through OTT carries health benefits.

“Just because we can do this, should we?” she said. “And will it do the things that we think it will? Does preventing or delaying menopause delay the aging process? I think that’s what they’re trying to imply, and we don’t have evidence that that’s true.”

The study was funded by the National Science Foundation, U-Anschutz Department of Obstetrics and Gynecology Research Funds, SF Faculty Early Career Development Program, and the National Institutes of Health awards. The authors reported no disclosures.

A version of this article appeared on Medscape.com.

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Clock Watchers

Article Type
Changed
Tue, 03/19/2024 - 23:07

The following scenario was discussed during a forum at a meeting recently:

Two employees managing the front desk are clock watchers, always the first to leave at 11:59 a.m. for lunch and at 4:59 p.m. for the end of the day no matter what is happening. This leaves the other employees stuck with their work.

I have seen clock watching often enough to know that it is widely practiced, and widely reviled by coworkers and managers alike. Generally, clock watchers — sometimes referred to in modern parlance as “quiet quitters” — radiate a palpable sense of “I don’t want to be here.”

Physicians typically can’t identify with clock watching behavior, because we learned early on that patient-care tasks must be pursued to completion; if that involves working past the usual “quitting time,” so be it. So your first task in dealing with this problem is to determine its cause. The clock watcher label may be unfair. There may be legitimate reasons for certain employees to leave work at precisely 4:59 every day. Perhaps they must pick up children, or they have a second job to get to. The label usually comes from a pattern of consistent, repeated behavior. And if more than one employee is exhibiting the same behavior in the same office, the likelihood of a valid explanation decreases proportionally.

Utamaru Kido/Moment/Getty Images

A common cause of clock watching is a lack of employees’ commitment to their jobs. They don’t see the point in putting in extra effort, so they run out the door as soon as possible. There are many reasons why this might be the case. For example, the workload in your office may be too large to be accomplished in the time available by the number of people you employ. The solution might be to simply hire additional personnel.

Another common cause is a lack of communication between physicians, managers, and lower-level employees. If staffers are raising concerns or potential solutions, and management is not listening to their opinions or ideas, they will stop offering them. Alternatively, other staff members may not be pulling their weight. When there is a large imbalance in the contribution of team members, the higher performers will stop trying.

Dr. Joseph S. Eastern

Over my 40 plus years in practice, I have had my share of clock watchers. I try the best I can not to let employees’ time commitment practices impact my valuation of their work. I always attempt to focus on quality and productivity. It isn’t easy, but I always try to address the issues behind clock watching behavior. As such, I can’t recall ever having to fire anyone for clock watching. Here are some of the strategies that have worked for me over the years:

1. Set clear expectations. Clearly communicate job responsibilities and expectations regarding time management and patient care. Ensure that all staff understand the importance of dedicating the necessary time to each patient, regardless of the time of day.

2. Foster a patient-centered culture. Cultivate a work environment that prioritizes patient care above all. This can help shift the focus from watching the clock to ensuring high-quality patient care.

3. Provide adequate breaks. Ensure that staff schedules include sufficient breaks. Overworked staff are more likely to watch the clock. Adequate rest periods can help alleviate this issue.

4. Offer flexibility where possible. If feasible, offer some degree of scheduling flexibility. This can help staff manage their personal time more effectively, potentially reducing the tendency to watch the clock.

5. Implement time management training. Offer training sessions focused on time management and efficiency. This can help staff manage their duties more effectively, reducing the need to constantly check the time.



6. Encourage open communication. Create an environment where staff feel comfortable discussing their concerns, including issues related to workload and time management. This can help identify and address specific factors contributing to clock watching.

7. Monitor and provide feedback. Regularly monitor staff performance and provide constructive feedback. If clock watching is observed, discuss it directly with the employee, focusing on the impact on patient care and the work environment.

8. Recognize and reward. Acknowledge and reward staff who consistently provide high-quality care and demonstrate effective time management. Recognition can motivate others to adjust their behavior.

9. Evaluate workloads. Regularly assess staff workloads to ensure they are manageable. Overburdened employees are more likely to engage in clock watching.

10. Lead by example. Management should model the behavior they wish to see in their staff. Demonstrating a commitment to patient care and effective time management can set a positive example.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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The following scenario was discussed during a forum at a meeting recently:

Two employees managing the front desk are clock watchers, always the first to leave at 11:59 a.m. for lunch and at 4:59 p.m. for the end of the day no matter what is happening. This leaves the other employees stuck with their work.

I have seen clock watching often enough to know that it is widely practiced, and widely reviled by coworkers and managers alike. Generally, clock watchers — sometimes referred to in modern parlance as “quiet quitters” — radiate a palpable sense of “I don’t want to be here.”

Physicians typically can’t identify with clock watching behavior, because we learned early on that patient-care tasks must be pursued to completion; if that involves working past the usual “quitting time,” so be it. So your first task in dealing with this problem is to determine its cause. The clock watcher label may be unfair. There may be legitimate reasons for certain employees to leave work at precisely 4:59 every day. Perhaps they must pick up children, or they have a second job to get to. The label usually comes from a pattern of consistent, repeated behavior. And if more than one employee is exhibiting the same behavior in the same office, the likelihood of a valid explanation decreases proportionally.

Utamaru Kido/Moment/Getty Images

A common cause of clock watching is a lack of employees’ commitment to their jobs. They don’t see the point in putting in extra effort, so they run out the door as soon as possible. There are many reasons why this might be the case. For example, the workload in your office may be too large to be accomplished in the time available by the number of people you employ. The solution might be to simply hire additional personnel.

Another common cause is a lack of communication between physicians, managers, and lower-level employees. If staffers are raising concerns or potential solutions, and management is not listening to their opinions or ideas, they will stop offering them. Alternatively, other staff members may not be pulling their weight. When there is a large imbalance in the contribution of team members, the higher performers will stop trying.

Dr. Joseph S. Eastern

Over my 40 plus years in practice, I have had my share of clock watchers. I try the best I can not to let employees’ time commitment practices impact my valuation of their work. I always attempt to focus on quality and productivity. It isn’t easy, but I always try to address the issues behind clock watching behavior. As such, I can’t recall ever having to fire anyone for clock watching. Here are some of the strategies that have worked for me over the years:

1. Set clear expectations. Clearly communicate job responsibilities and expectations regarding time management and patient care. Ensure that all staff understand the importance of dedicating the necessary time to each patient, regardless of the time of day.

2. Foster a patient-centered culture. Cultivate a work environment that prioritizes patient care above all. This can help shift the focus from watching the clock to ensuring high-quality patient care.

3. Provide adequate breaks. Ensure that staff schedules include sufficient breaks. Overworked staff are more likely to watch the clock. Adequate rest periods can help alleviate this issue.

4. Offer flexibility where possible. If feasible, offer some degree of scheduling flexibility. This can help staff manage their personal time more effectively, potentially reducing the tendency to watch the clock.

5. Implement time management training. Offer training sessions focused on time management and efficiency. This can help staff manage their duties more effectively, reducing the need to constantly check the time.



6. Encourage open communication. Create an environment where staff feel comfortable discussing their concerns, including issues related to workload and time management. This can help identify and address specific factors contributing to clock watching.

7. Monitor and provide feedback. Regularly monitor staff performance and provide constructive feedback. If clock watching is observed, discuss it directly with the employee, focusing on the impact on patient care and the work environment.

8. Recognize and reward. Acknowledge and reward staff who consistently provide high-quality care and demonstrate effective time management. Recognition can motivate others to adjust their behavior.

9. Evaluate workloads. Regularly assess staff workloads to ensure they are manageable. Overburdened employees are more likely to engage in clock watching.

10. Lead by example. Management should model the behavior they wish to see in their staff. Demonstrating a commitment to patient care and effective time management can set a positive example.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The following scenario was discussed during a forum at a meeting recently:

Two employees managing the front desk are clock watchers, always the first to leave at 11:59 a.m. for lunch and at 4:59 p.m. for the end of the day no matter what is happening. This leaves the other employees stuck with their work.

I have seen clock watching often enough to know that it is widely practiced, and widely reviled by coworkers and managers alike. Generally, clock watchers — sometimes referred to in modern parlance as “quiet quitters” — radiate a palpable sense of “I don’t want to be here.”

Physicians typically can’t identify with clock watching behavior, because we learned early on that patient-care tasks must be pursued to completion; if that involves working past the usual “quitting time,” so be it. So your first task in dealing with this problem is to determine its cause. The clock watcher label may be unfair. There may be legitimate reasons for certain employees to leave work at precisely 4:59 every day. Perhaps they must pick up children, or they have a second job to get to. The label usually comes from a pattern of consistent, repeated behavior. And if more than one employee is exhibiting the same behavior in the same office, the likelihood of a valid explanation decreases proportionally.

Utamaru Kido/Moment/Getty Images

A common cause of clock watching is a lack of employees’ commitment to their jobs. They don’t see the point in putting in extra effort, so they run out the door as soon as possible. There are many reasons why this might be the case. For example, the workload in your office may be too large to be accomplished in the time available by the number of people you employ. The solution might be to simply hire additional personnel.

Another common cause is a lack of communication between physicians, managers, and lower-level employees. If staffers are raising concerns or potential solutions, and management is not listening to their opinions or ideas, they will stop offering them. Alternatively, other staff members may not be pulling their weight. When there is a large imbalance in the contribution of team members, the higher performers will stop trying.

Dr. Joseph S. Eastern

Over my 40 plus years in practice, I have had my share of clock watchers. I try the best I can not to let employees’ time commitment practices impact my valuation of their work. I always attempt to focus on quality and productivity. It isn’t easy, but I always try to address the issues behind clock watching behavior. As such, I can’t recall ever having to fire anyone for clock watching. Here are some of the strategies that have worked for me over the years:

1. Set clear expectations. Clearly communicate job responsibilities and expectations regarding time management and patient care. Ensure that all staff understand the importance of dedicating the necessary time to each patient, regardless of the time of day.

2. Foster a patient-centered culture. Cultivate a work environment that prioritizes patient care above all. This can help shift the focus from watching the clock to ensuring high-quality patient care.

3. Provide adequate breaks. Ensure that staff schedules include sufficient breaks. Overworked staff are more likely to watch the clock. Adequate rest periods can help alleviate this issue.

4. Offer flexibility where possible. If feasible, offer some degree of scheduling flexibility. This can help staff manage their personal time more effectively, potentially reducing the tendency to watch the clock.

5. Implement time management training. Offer training sessions focused on time management and efficiency. This can help staff manage their duties more effectively, reducing the need to constantly check the time.



6. Encourage open communication. Create an environment where staff feel comfortable discussing their concerns, including issues related to workload and time management. This can help identify and address specific factors contributing to clock watching.

7. Monitor and provide feedback. Regularly monitor staff performance and provide constructive feedback. If clock watching is observed, discuss it directly with the employee, focusing on the impact on patient care and the work environment.

8. Recognize and reward. Acknowledge and reward staff who consistently provide high-quality care and demonstrate effective time management. Recognition can motivate others to adjust their behavior.

9. Evaluate workloads. Regularly assess staff workloads to ensure they are manageable. Overburdened employees are more likely to engage in clock watching.

10. Lead by example. Management should model the behavior they wish to see in their staff. Demonstrating a commitment to patient care and effective time management can set a positive example.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

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